Device |
direct blood bacterial nucleic acid detection system |
Regulation Description |
Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens. |
Definition |
Amplification, detection and identification of microbial pathogens directly from whole blood specimens |
Physical State |
The direct blood bacterial nucleic acid detection system consists of reagents and disposables. The associated instrumentation performs the amplification of bacterial nucleic acid, detects the amplified products and reports results. |
Technical Method |
A multiplexed nucleic acid amplification assay that amplifies and detects bacterial DNA in whole blood specimens |
Target Area |
Nucleic acids of bacteria |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QBX |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3960
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |